To help you better understand clinical studies, we have prepared a number of questions and answers commonly asked by potential study volunteers. We have also provided links to organizations that will provide you with more information on clinical studies.
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Common Questions Asked By Potential Volunteers About Clinical Research Studies
What is a clinical research study?
A clinical research study is a type of research that is led by a physician (study doctor) with the assistance of his/her staff to evaluate the safety and effectiveness of investigational medications, medical devices, medical procedures or other health interventions. Investigational medications or medical devices that are tested in a clinical research study are often not approved for use in Canada (i.e., are not available for general medical use).
Why are clinical research studies done?
A clinical research study may be conducted to evaluate the effectiveness and/or safety of an investigational medication, device or procedure for a given medical condition. This is often done by comparing the study medication to placebo (or sugar pill, see below) or to an approved medication, or by comparing different doses of a study medication. The clinical research study may also test how a study medication is handled in the body. The information collected in clinical studies can be used to obtain approval to market a new investigational medication/device or to learn more about an already approved medication/device (e.g., looking at its use for treating other diseases).
Who can participate in a clinical research study?
While participation in a study is entirely voluntary, not all volunteers are accepted into clinical research studies. Each volunteer must meet specific eligibility criteria for a given study such as age, sex, type and stage of disease, other medical conditions and treatment history. These criteria are developed to reduce the chances that the study results were from a change in the underlying disease, or from another medication, or from other variables that could make the results less reliable. Volunteers may also be excluded from participation in a clinical study if the study doctor has already recruited a sufficient number of volunteers.
Why do physicians participate in clinical research studies?
By conducting clinical research studies, study doctors have the opportunity to:
Are physicians paid to participate in clinical research studies?
Physicians who take time away from their regular practice to participate in clinical research studies are paid for the work that they perform. Since it is not known whether the study medication or device will be found suitable by Health Canada to be marketed, companies that have to pay for the clinical study must try to keep the costs as reasonable as they can. The fees physicians earn are similar to what they would earn for performing services for other parties, such as completing forms and conducting physical exams for insurance companies.
What are potential advantages for volunteers who participate in a clinical research study?
There are various reasons for participating in a clinical research study:
What are potential disadvantages for volunteers who participate in a clinical research study?
Depending on the nature of the clinical research study, participation may be time consuming and at times, inconvenient. There may also be certain medications that you will not be allowed to take while participating in the study and other restrictions. In addition, there are risks associated with all treatments and procedures. You have to be informed of known risks related to the study medication and study procedures but there may be risks that are unknown or unexpected.
What is a Placebo?
A placebo is sometimes referred to as a ‘sugar pill’, but it may also take the form of a liquid, spray or other formulation. The placebo resembles the study medication being tested. Placebo is used for comparison purposes; i.e., to see if the study medication being tested is more effective than no treatment at all. Not all studies include a placebo; you have to be informed if there is a possibility that you may receive a placebo.
How do I find out about the nature of my involvement in a clinical research study?
You will be given an informed consent form to review before any study related procedures are performed. The consent form contains all of the information about the study. It describes the purpose of the study; the study medications involved and how they will be administered; known risks and potential benefits of participation; the procedures required; time commitment involved and the duration of your participation in the study. It will also describe your rights as a research participant. If you wish to participate in a clinical study, you must understand all of the information contained in the informed consent form and should ask questions of the study doctor or his/her staff if anything is unclear. By signing the informed consent form, you are documenting that you have been given information about the study, and your voluntary consent to participate.
What rights do I have as a research volunteer (or participant)?
Health Canada and other government agencies set forth laws and guidelines for the proper conduct of clinical research studies. These laws and guidelines require that complete and accurate information about the clinical study is given to participants and that their rights and safety are protected. An ethics committee that is independent of the study doctor and the company sponsoring the clinical study must also review the clinical study. The ethics committee is responsible for helping to ensure that ethical standards are applied to clinical studies that they oversee. They help safeguard the rights, safety, and well being of all clinical study subjects.
How will my personal information be protected?
You will be informed of the following during the informed consent process:
What if I change my mind about participating?
You have the right to change your mind about participating in a clinical research study even after you have signed the consent form. If you decide to withdraw, you should inform the study doctor of your decision as soon as possible. You will be invited to attend a final visit in order to conduct final assessments related to the study goals and/or final safety assessments. There is no penalty or loss of benefits to you for withdrawing your consent.
For more information about participating in clinical research studies, please visit the following websites:
Health Canada – Clinical Trials and Drug Safety
https://www.hc-sc.gc.ca/hl-vs/iyh-vsv/med/clinical_trials-essais_cliniques-eng.php
The Center for Information and Study on Clinical Research Participation (CISRP)
https://www.ciscrp.org
ClinicalTrials.gov
https://clinicaltrials.gov/ct2/about-studies/learn
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